A
Congressional war is being waged in America's capital regarding
whether drug manufacturers should

have the
right to retain patents which they acquired by breaking the rules or
engaging in unscrupulous misrepresentation. This matter of contention
has created a muddled legal climate in regard to efforts to reform
the existing patent structure.

In a
number of recent court cases, judges have reneged on patents after it
was discovered that the companies that acquired particular patents
misled the Patent and Trademark Office in order to obtain a patent
that they did not deserve. Patent law legislation affects a huge
portion of the United States economy, and the current affair has left
lobbyists both for and against patent law reform with flush pockets.
Over the past fifteen months, two corporate coalitions have been in a
fierce battle for the ears of members of Congress, spending a total
of $4.3 million dollars making their cases both for and against
patent law reform.

New
Changes in Patent Law Up for Debate

The
changes which are up for debate at this time represent the most
massive potential overhaul in American patent law in the last
half-century. Corporate representatives from nearly every significant
United States industry have thrown their hats into the ring.
Currently, patents give their owners the rights to their invention
for a period of up to twenty years. As a means to defend against
illegitimate patents, Federal courts have the jurisdiction to cancel
patents if they discover that corporations acquired their patent
through nefarious means, such as hiding or misrepresenting data in
order to trick the patent office into issuing an unwarranted patent.
If a patent has been found to have been earned in this manner, a
federal court can nullify the patent, canceling its validity.

Senior V.P
of the pharmaceutical manufacturer Eli Lilly, Robert Armitage,
believes that this form of nullification is a miscarriage of justice.
He compares it to sentencing a person to death for a simple
misdemeanor. In his eyes, it's simply a gross misuse of force.
Pharmaceutical companies that deal in Trademarked drugs are lobbying
Congress in order to soften or eliminate this penalty for misconduct
as it is currently encoded into law.

Debra
Barrett is a the primary representative speaking for generic
pharmaceutical companies. She is the V.P. Of the American arm of Teva
Pharmaceutical, which is the biggest generic medicinal manufacturer
on earth. She argues that the changes lobbied for by the designer
pharmaceutical companies would create an unfair playing field in
which drug companies that deal primarily in patented drugs would have
an unfair advantage which essentially gives them a blank check to
deceive the market. This change in patent law would make it easier
for companies to retain ill-gotten patents and prevent useful and
lifesaving drugs from reaching the generic market in a time frame
that is supposedly ensured by law.

Consumer
Advocates Weigh In

In
addition to generic drug companies, consumer advocate organizations
such as the American Association of Retired Persons are also
concerned about the abuse of patent law which they feel has the
potential to hurt customers. Groups like the AARP are ultimately
concerned with ensuring that drugs enter the generic market at a
timely pace. These generic drugs can be up to eighty percent cheaper
than their trademarked counterparts. The AARP understands that there
are many forms of therapy such as HGH Hormone Replacement Therapy and
other health treatments which can potentially provide incredible
benefits to seniors, and the earlier that these drugs are made
available to the generic market, the more seniors will have the
opportunity to utilize such therapies.

Current
Activity in the House and Senate

The House
of Representatives ultimately sided with the brand name
pharmaceutical manufacturers and have passed a bill that would
decrease the judicial systems ability to nullify patents for reasons
of misconduct. The Senate has yet to come to agreement on a similar
bill which was presented by the Senate Judiciary Committee, but it is
expected that the bill will reach the floor of the Senate in the
summer of 2008.

The
Recent History of Inequitable Patent Conduct

From 1993
to 2008, the judiciary construct responsible for patent law cases,
known as the U.S. Federal Circuit Court of Appeals, has discovered
proof of misleading conduct in at least forty cases that were brought
to trial. Among these cases were fourteen cases which involved health
care and pharmaceutical patents. District court justices have also
come to find similar results in an unidentified number of patent law
cases in which appeals were not sought. In these cases, the courts
discovered that pharmaceutical manufacturers presented knowingly
untrue statements to the United States Patent Office in which they
hid contradictory evidence and purposefully explained their
experiments in a manner which was selectively inaccurate.

In one
particularly telling case, the U.S. Court of Appeals explained that
the drug manufacturer Novo Nordisk purposefully lied to the patent
office regarding an experiment which they claimed to have performed
when making the case for their patent for a form of Bio-Identical
Human Growth Hormone. In a similar case, the drug company Pharmacia
produced a misleading and inaccurate sworn statement when seeking a
patent for a glaucoma drug.

Brand
Name Versus Generic

Trademark
drug companies accuse generic pharmaceutical manufacturers of being
over-litigious, attacking patents haphazardly even if there is no
proof of inequity, or unfairly targeting cases which unintentional
but minor mistakes were made in patent acquisition. The brand name
pharmaceutical manufacturers believe that aggressive claims of
iniquity have become a major hindrance on the normal activity of the
patent system. One of the primary interest groups that lobbies from
this perspective is a trade association known as the Biotechnology
Industry Organization. The BIO represents drug manufacturers that
research modern medical treatments such as Testosterone Replacement
Therapy and other patented Hormonal Therapies, among various other
pharmaceuticals.

A
Presidential Advisor Weighs In

The
commissioner of trademarks and patents under George H.W. Bush was
Harry Manbeck Junior. He believes that the current legal construct
regarding patent inequity is a needed and sufficient deterrent to
prevent unscrupulous patent conduct. He believes that it is important
to recognize the potentially immense value of the patent. He goes on
to say that companies have powerful incentives to acquire them, and
that even with the current nullification structure in place, certain
corporations still occasionally make the conscious decision to
subvert the law. Mr. Manbeck maintains that the doctrine of
inequitable conduct is a necessary construct which helps weed out the
existence of ill-gotten patents.

How the
Current Law Works

Under
existing national regulations, individuals who seek to attain patents
have an obligation to be honest when interacting with the United
States Patent Office. They are required to speak with honesty, good
faith, and candor. Patent-seekers are required to tell patent office
officials if the invention which they present was first used by some
other individual or entity, or if the invention was previously
discovered by some other individual or group. They are also required
to disclose whether the product has been put up for sale or
delineated previously in some form of publication. If any of those
circumstances are true, the patent office may make the decision that
the patent sought is not original enough to be approved.

The
Opinion of the Patent Office Professional Union

Although
the patent office makes reasonable efforts to uncover existing forms
of any potential patents presented to them, it is impossible for
officials to review all of the relevant information in its entirety
due to the volume of such information. For this reason, it is of the
utmost importance that applicants be honest and upfront with all of
the information that they have unveiled. Robert Budens is the
executive officer representing the Patent Office Professional
Association. This organization is a union which represents the needs
of over 5,500 patent examiners across the United States. He believes
that the patent inequity laws on the books are vitally important to
the underlying purpose of the United States Patent Office, which is
to protect the intellectual property of individuals who engage in
genuine innovative activity. Weak patent inequity laws undermine this
underlying purpose.

Some
Consider Abuse inherent in the Current System

On the
other hand, the executive representing Eli Lilly, Mr. Armitage,
argues that the rules regarding inequitability are being abused by
individuals and companies who wish to nullify legitimate patents for
their own gain. The doctrine of inequibility is being cited with such
frequency that it is creating an entire set of unintended
consequences.

The
executive officer of the BIO, James Greenwood, laments the plight of
the overwhelmed patent official, claiming that individuals have a
tendency to provide mountains of non-vital information to the United
States Patent office in an attempt to avoid being perceived as hiding
any information. In addition to this, they do little to explain the
information that they provide to the patent officer because they fear
that they will accidentally be misconstrued as having misrepresented
the information they provided to the patent office. In the end,
Greenwood claims, the examiner of the patent is forced to read
through reams of information provided by the patent applicant with no
guidance whatsoever as a result of the strict laws in place regarding
inequitable conduct.

The
Modern Surge of Patent Applications

Applications
for patents have grown exponentially in the past two decades. A total
of 467,243 patents were applied for in the year 2007. This number is
twice the number applied for in 1997 and three times the number
applied for in 1997.

The
Undersecretary of Intellectual Property Commerce, Jon Dudas, says
that there aren't more inventions than their were twenty years ago,
there are more false leads and ideas which are unpatentable. The
quality of the applications has dropped precipitously in the last
generation.

Over the
course of the last forty years, the fraction of applications which
were approved for patent existed in a range of 62%-72%. In the year
2000, the percentage of successful patent applications peaked at 72%,
but eight years later, the number of actionable patents has dropped
to only 43% in the first business quarter of 2008..

Why is
Patent Law Important To Technological and Pharmaceutical Companies?

One of the
major reasons that existing patent law is at risk is because
technological companies have an innate desire to restrict legal costs
and damage settlements that occur when patent infringement is
discovered. Corporations such as Palm and Cisco claim that these
legal quarrels drain precious funding that would better serve both
corporations and Americans at large if invested in innovation and
research.

New
Lobbying Firms Arise

A new
lobbying firm has coalesced as a result of the unified needs of these
patent-driven tech companies. This firm is known as the Coalition for
Patent Fairness. Over the past five business quarters, the coalition
has spent over $2.5 million on a large retinue of lobbyists which
represent both Democrats and Republicans. The primary Democratic
representative Democratic strategist Steven Elmendorf. The primary
Republican representative is Mark Isakowitz.

A similar
lobbying group known as the Coalition for Twenty-First Century Patent
Reform has also formed, which represents fifty corporations which
defend their patents and trademarks with zeal. These corporations
have classically been known for their propensity to file lawsuits in
defense of their existing patents. This coalition includes
biotechnology companies and pharmaceutical companies such as Pfizer,
Merck, Eli Lilly, and Genzyme. This group of corporations has spent
almost $2 million dollars funding lobbyists working in their favor.
The biggest recipient of money from the coalition is a legal team
administered by Akin Gump.

Patent law
plays a major role in medical and technological innovation, and
hopefully in the near future, laws will be both improved and
streamlined in order to optimize the relationship between medical
innovation and improved health outcomes for Americans.

Information
Collected from www.newyorktimes.com

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